510(k) K820867 ยท GBO Catheter, Nephrostomy, General & Plastic Surgery
PERCUTANEOUS NEPHROSTOMY SET
| Applicant | Van-Tec, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 13, 1982 |
| Received | Mar 29, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M001225240 VTC FIRM KIT 8
M001225140 VTC FIR Terminated |
GBO | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN # Description
M0064102040 Percuflex Locking Loop Nephrostomy Catheters
Terminated |
FGE | None listed |
| May 21, 2009 | Boston Scientific Corporation Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style)
UPN# DESCRIPTION
M0064101110 Percutaneous Nephrostomy Catheters Percutaneous
Terminated |
FGE | None listed |
| Jul 20, 2004 | Boston Scientific Corp Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; mode Terminated |
GBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.